What are Dietary Supplements?
Dietary supplements are products taken by mouth that contain dietary ingredients and are intended to supplement the diet. A dietary ingredient may be a vitamin, mineral, herb, botanical, or a concentrate (including metabolites, constituents, and extracts). In economically advanced countries, dietary supplements are used by 50% of adults and one third of children; the global business is worth more than 100 billion dollars annually.
What do Dietary Supplements do for your Body?
The main intent of dietary supplements is to provide additional nutrition to people who may be deficient. Certain dietary supplements are marketed as a way to lose weight, gain muscle, or boost energy. They are also sometimes taken as a preventative measure for certain diseases, though the packaging/label has to say, “this product is not meant to cure, treat, or prevent any disease or illness” as required by the FDA.
Consumers are aware of the health benefits of various dietary supplement ingredients, so advertisement of that ingredient in effect advertises its effect on the body. Congress demonstrated a level of comfort in this with the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA), which limited the Federal Drug Administration’s (FDA) oversight of such products by categorizing dietary supplements as foods and not drugs. Since they are regulated as foods, there are no requirements to demonstrate effectiveness unless the labeling or advertising claims health benefits or other effects. These claims are regulated by the FDA and will only be authorized if the claim is supported by people with the technical background and training to do so. In almost all cases, a dietary supplement claiming to change or otherwise affect the structure or function of the body would fall into the category of a new drug, subject to drug regulations.
Who Needs Dietary Supplements?
People with certain vitamin or mineral deficiencies use dietary supplements as a means to increase the amount of various foods or food components in their system. An example is an iron deficient person taking iron supplements to stabilize their iron levels. Athletes are another group that may have a need for supplements (e.g., protein and certain amino acids), understanding that they may enhance recovery and/or improve athletic performance.
What are Responsibilities of Dietary Supplement Manufacturers?
The primary regulatory obligations of manufacturers of dietary supplements is to ensure that the label describes the product identity and composition accurately and to ensure the product is safe.
To ensure safety and label accuracy, dietary supplement manufacturers do the following:
- Manufacture products in accordance with the Dietary Supplement Good Manufacturing Practices at 21 CFR Part 111.
- Test the identity, strength, and purity of all ingredients.
- Conduct Dietary Supplement Testing, including to
- Test the product to ensure it’s below microbial limits for dietary supplements using <USP> 2021.
- Test the product to ensure it’s free from specific pathogens using <USP> 2022.
Dietary supplements have the added necessity to ensure what they are consuming is legitimate as there have been incidents of inadvertent doping due to supplements being adulterated (contaminated or spiked) with Schedule I or Schedule II substances (e.g., growth factors, stimulants, hormone modulators). Overall though, the composition of populations taking dietary supplements is extremely diverse and non-homogenic as consumption is dependent on individual people.
